Trial intelligence / Profile preview

CC-220 (Iberdomide) Monotherapy and Combination Therapy in Multiple Myeloma

NCT02773030Phase 2

Key facts

Status
Active, not recruiting
Start
Oct 2016
Primary completion
May 2024
Countries
11
Modality
Small Molecules
Conditions
multiple myeloma (MM)
01

Overview

Phase 2, open-label trial of iberdomide in multiple myeloma (MM) (11 cohorts), sponsored by Celgene Corporation. Primary endpoints: Dose Limiting Toxicities at 28 days and Overall Response Rate at 22.11 weeks. Started Oct 2016; status: active, not recruiting.

02

Design

11 arms
Study design
Non-randomizedOpen-label
  • Cohort A: CC-220 Monotherapy - Part 1

    CC-220 monotherapy dose escalation.

  • Cohort B: CC-220 + DEX - Part 1

    CC-220 + Dexamethasone dose escalation.

  • Cohort D: CC-220 + DEX - Part 2

    CC-220 + Dexamethasone dose expansion.

  • Cohort E: CC-220 + DEX + DARA - Part 1

    CC-220 + Dexamethasone + Daratumumab dose escalation.

  • Cohort F: CC-220 + DEX + BTZ - Part 1

    CC-220 + Dexamethasone + Bortezomib dose escalation.

  • Cohort G1: CC-220 + DEX + CFZ - Part 1

    CC-220 + Dexamethasone + Carfilzomib dose escalation.

5 more in the full profile.

03

Who it enrols

Patients with relapsed/refractory or newly diagnosed multiple myeloma with measurable disease, adequate organ function, and ECOG PS 0-2. Excludes nonsecretory MM, plasma cell leukemia, amyloidosis, and peripheral neuropathy >= Grade 2.

04

Endpoints

Primary

  • Dose Limiting Toxicities

  • Overall Response Rate

Secondary

  • Treatment Related Adverse Events

  • Adverse Events of Special Interest

  • Very Good Partial Response Rate

  • Overall Response Rate

  • Time to Response

  • Duration of Response

  • Progression Free Survival

  • Overall Survival

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